AU2005282502B2

AU2005282502B2 - Topical medicament

Info

Publication number: AU2005282502B2
Application number: AU2005282502A
Authority: AU
Inventors: Clyde Morgan
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-09-08
Filing date: 2005-09-07
Publication date: 2011-01-27
Anticipated expiration: 2025-09-07
Also published as: CA2579338A1; US8541034B2; US20080069903A1; WO2006029189A3; US8048447B2; WO2006029189A2; US20060051432A1; CA2579338C; US7704522B2; GB2432314B; GB0704141D0; US20090017138A1; GB2432314A; AU2005282502A1

Description

1 TOPICAL MEDICAMENT BACKGROUND OF THE INVENTION Related Applications 5 This application claims the priority benefit of U.S. Provisional Patent Application No. 60/608,136, filed September 8, 2004, incorporated by reference herein. Field of the Invention The present invention is broadly concerned with improved topical medicaments in 10 forms of creams or lotions which are useful in the treatment of a variety of conditions that are ameliorated by increased cell metabolism, circulation, and nerve function. More particularly, the invention is concerned with such medicaments having a gel base with menthol and camphor, and supplemented with potassium and an oxygen source such as an alkali metal chlorite. 15 Description of the Prior Art A variety of topically applied creams and lotions have been developed in the past for treatment of conditions such as arthritis and muscle pains. One such product is commercialized under the designation SOMBRA. This product contains 3% menthol and 3% 20 camphor, in a gel base, and is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises, and sprains. However, many prior art creams and lotions do not adequately treat these conditions in most people. Furthermore, even those that are successful do not sustain metabolic activity for extended periods of time, thus making any relief experienced rather temporary. There is a need 25 for new treatments that provide relief for a wide variety of conditions and for extended periods of time. A reference herein to a patent document or other matter which is given as prior art is not to be taken as an admission that that document or matter was known or that the information it contains was part of the common general knowledge as at the priority date of 30 any of the claims. SUMMARY OF THE INVENTION The present invention overcomes these problems by broadly providing novel topical medicaments having improved metabolic activity.

WO 2006/029189 PCT/US2005/031819 2 In more detail, the inventive medicaments comprise menthol, camphor, potassium, and a source of oxygen. The menthol and camphor can be individually added to the composition, or they can be added via a base composition including menthol and camphor. One preferred base composition is a gel sold under the name SOMBRA. Regardless of the 5 delivery source, the menthol is preferably present in the medicament at a level of at least about 0.5% by weight, more preferably from about 2-20% by weight, and even more preferably from about 2-4% by weight, based upon the total weight of the medicament taken as 100% by weight. Furthermore, the camphor is preferably present in the medicament at a level of at least about 0.5% by weight, more preferably from about 2-20% 10 by weight, and even more preferably from about 2-4% by weight, based upon the total weight of the medicament taken as 100% by weight. The potassium is preferably provided in powder form, and it can be obtained from dietary supplements, for example. One preferred source ofpotassium is Potassium Chelate (99 mg potency) sold by Nature's Way. Potassium Chelate is provided in the form of a 15 capsule including powder potassium and minor amounts of ground millet. The capsule can simply be opened, and the powder from the capsule used in the present invention. Potassium is preferably present in the medicament at a level of at least about 0.02% by weight, more preferably from about 0.04-0.5% by weight, and even more preferably from about 0.09-0.2% by weight, based upon the total weight of the medicament taken as 100% 20 by weight. When Potassium Chelate or a similar product is used, preferably from about 1-20 capsules, more preferably from about 1-15 capsules, and even more preferably from about 8-13 capsules are used. The source of oxygen can be any source that is capable of delivering the appropriate levels of oxygen to the medicament. Suitable oxygen sources include those selected from 25 the group consisting ofchlorites (and preferably alkali metal chlorites such sodium chlorite and magnesium chlorite), spirulina, and mixtures of the foregoing. The most preferred oxygen source is sold under the name AEROBIC 07, which contains deionized water, sodium chlorite, carbonates, and bicarbonates. The oxygen source is preferably present in the medicament in sufficient quantities 30 to provide oxygen levels of at least about 0.016% by weight, more preferably from about 0.10-0.85% by weight, and even more preferably from about 0.17-0.25% by weight, based WO 2006/029189 PCT/US2005/031819 3 upon the total weight of the medicament taken as 100% by weight. When AEROBIC 07 or a similar product is used, it is preferably added at levels of from about 1-13 drops, more preferably from about 1-10 drops, and even more preferably about 4 drops. In one alternative embodiment, the medicament also includes a source of chlorine 5 ions. If sodium chlorite is used as the source of oxygen, it will also functions as a source of chlorine ions. Other suitable sources of chlorine ions include any chlorite (e.g., sodium hypochlorite) such as those found in commercially available bleaching agents (e.g., CLOROX, CALIBEX). In these embodiments, the source of chlorine is included in sufficient quantities to provide chlorine ion levels of from about 0.10-10% by weight, and 10 more preferably from about 0.16-0.85% by weight, based upon the total weight of the medicament taken as 100% by weight. The inventive medicaments can also include a number of optional ingredients, depending upon the final use. Some suitable ingredients include those selected from the group consisting of aloe vera extract, capsaicin, carbomer, decyl plyglucose, deionized 15 water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, silica, sodium hydroxymethyl glycinate, vegetable glycerin, witch hazel, yucca extract, carbonates, bicarbonates, and mixtures of the foregoing. The preferred quantities of these ingredients are set forth in Table 1. These ingredients can be added individually or in a group as part of another composition (e.g., in a base composition 20 such as SOMBRA).

WO 2006/029189 PCT/US2005/031819 4 Table 1 INGREDIENT BROAD RANGE MORE PREFERRED RANGEA Aloe Vera Extract 0.10-50% 0.25-1.75% Capsaicin 0.001-10% 0.25-1.75% 5 Carbomer 1.35-30% 2.75-19.25% Decyl Plyglucose 0.1-9% 0.5-3.5% Deionized Water 20-90% 76.5-90% Grapefruit Seed Extract 0.001-5% 0.25-1.75% Green Tea Extract 0.05-10% 0.5-3.5% 10 Orange Peel Extract 0.001-5% 0.25-1.75% Queen of the Prairie Extract 0.25-20% 2.25-15.75% Rose Water 0.2-7% 0.5-3.5% Silica 0.03-20% 1-7% Sodium Hydroxymethyl 0.05-25% 1.25-8.75% 15 Glycinate Vegetable Glycerin 0.09-50% 1.75-12.25% Witch Hazel 0.02-15% 1-7% Yucca Extract 0.015-30% 0.5-3.5% Carbonates 0.025-3.5 % 0.25-1.75% 20 Bicarbonates 0.025-3.5% 0.25-1.75% A The percentages by weight are based upon the total weight of the topical medicament taken as 100% by weight. The inventive medicaments are formed by simply mixing the above ingredients 25 together, preferably in some type of carrier. If SOMBRA is used, then the carrier is provided by that product. In a particularly preferred preparation method, aprecursor composition containing the camphor and menthol is provided. The precursor composition should comprise: WO 2006/029189 PCT/US2005/031819 5 from about 1-10% by weight menthol, preferably from about 1-5% menthol, and even more preferably about 3% by weight menthol; and from about 1-10% by weight camphor, preferably from about 1-5% 5 camphor, and even more preferably about 3% by weight camphor, based upon the total weight of the medicament taken as 100% by weight. The precursor composition can also include some or all of the optional ingredients discussed above. 10 A quantity of the precursor composition is added to a container, along with a portion of the potassium. Further respective quantities of the precursor composition and potassium are then added in alternating steps until the desired quantity as been obtained. The precursor composition and potassium within the container are preferably then mixed until substantially homogeneous (e.g., from about 1-3 minutes, and preferably about 2 15 minutes). Mixing can be carried out by hand or mechanical mixing means (e.g., mixer, shearing in industrial equipment). The source of oxygen is then added to the resulting mixture and further mixing is carried out. Any optional ingredients that were not already added can then be added to the mixture to yield the final medicament. The inventive topical medicament is used to treat a portion of the body (human or 20 animal) afflicted with an ailment by simply contacting the medicament with the afflicted portion of the body. The medicament is then preferably rubbed into the skin until it is no longer visible. It will be appreciated that the medicament can be used to treat numerous conditions, including diabetic neuropathy, post hepatic neuralgia, scleroderma, psoriasis, strain, spasticity, headaches, neuropathy secondary to drugs, peripheral neuropathy, leg 25 pain, muscle cramps, muscle aches and pains, bruise, sinusitis, sprain, arthritis, joint pain arthralgiaa), and edema. The inventive medicament offers a particularly significant advantage in that it achieves high metabolic activity and maintains that activity over extended periods of time. "Metabolic activity" as used herein refers to energy (in mV) that is created by the 30 potassium ions in the medicament. That energy is then transferred to the patient at the medicament location on the skin. Though not wishing to be bound by theory, it is believed WO 2006/029189 PCT/US2005/031819 6 that the energy excites and thus opens the sodium-potassium pumps in the cells. This stimulates the nervous system and better allows active ingredients to enter the cells. Metabolic activity is determined by mixing 1 g of a medicament with 0.1 g of a commercially available electrolyte material (e.g., one sold under the name ORAL 5 REHYDRATION SALTS, available from Jianas Bros. Packaging Co.). The mixture is then placed onto an electrogel pad, which is "sandwiched" between two ECG patches connected to a voltmeter. Readings in mV are taken over regular intervals (e.g., 5-minute intervals). When using the medicaments of the invention, a peak (i.e., highest or maximum) 10 metabolic activity of at least about 2.5 mV, preferably at least about 4 mV, and more preferably from about 4-20 mV is achieved. This peak is preferably achieved within about 30 minutes, and more preferably within about 15 minutes, of application to the afflicted area. The inventive medicaments also possess the property of having a retained 15 metabolic activity of at least about 20%, preferably at least about 30%, and even more preferably from about 50-100% over a 45-minute time period. Furthermore, the inventive medicaments possess the property of having a retained metabolic activity of at least about 5%, preferably at least about 20%, and even more preferably from about 25-100% over an 8-hour time period. As used herein, "retained metabolic activity" is determined as follows: 20 metabolic activity after 45 minutes or 8 hours Retained Metabolic Activity = x 100 peak metabolic activity 25 BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 a is a graph depicting the metabolic activity of a prior art product over a 30 45-minute time period; WO 2006/029189 PCT/US2005/031819 7 Fig. lb is a graph depicting the metabolic activity of another prior art product over a 45-minute time period; Fib. 1 c is a graph depicting the metabolic activity ofthe inventive medicament over a 45-minute time period; and 5 Fig. 1 d is a graph depicting the metabolic activity ofthe inventive medicament over an 8-hour time period. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 10 EXAMPLES The following examples set forth preferred methods in accordance with the invention. It is to be understood, however, that these examples are provided by way of illustration and nothing therein should be taken as a limitation upon the overall scope of 15 the invention. EXAMPLE 1 Preparation of Topical Medicament A 1-gallon plastic jug was tared on a Sunbeam Model SP5 top balance (no shield, 20 small pan balance). The jug was then charged with 5.7 oz of SOMBRA Natural Pain Relieving Gel (available from Sombra Inc., Albuquerque, NM). Thirteen potassium amino acid chelate capsules (99 mg potassium with millet filler; available from Nature's Way, Springville, UT) were emptied three at a time. The filled capsule weight was 0.78 g, the emptied powder weight was 0.67 g, and the empty capsule 25 weight was 0.67 g (n=1). The level of elemental potassium in the capsule was not given on the label. The powder emptied from the capsules was then added to the SOMBRA in the plastic jug as follows: (1) The jug was charged with SOMBRA to a weight of 12.1 oz., and the 30 powder from three empty capsules was added; WO 2006/029189 PCT/US2005/031819 8 (2) The jug was charged with SOMBRA to a weight of 1 lb. 6.1 oz., and the powder from three empty capsules was added; (3) The jug was charged with SOMBRA to a weight of 2 lb. 3.9 oz., and the powder from the remaining empty capsules was added; and 5 (4) The jug was charged to a final weight of 3 lb. 1 oz. with SOMBRA. A cap was placed on the jug, and the jug was shaken by hand for about 2 minutes to substantially evenly distribute the powder. The gel did not adhere to the plastic jug after the potassium amino acid chelate was added. AEROBIC 07 (a dietary supplement including deionized water, sodium chlorite, 10 carbonates, and bicarbonates; available from Aerobic Live, Phoenix, AZ) was used as a stabilized source of oxygen. Thirteen drops of the Aerobic 07 were added to the plastic jug containing the SOMBRA-potassium amino acid chelate mixture. The jug was again capped and shaken by hand for about 2 minutes to yield the final topical medicament. The final medicament was more viscous than the SOMBRA gel. When comparing a quantity 15 of each, the compounded medicament did not separate or flow as compared to the SOMBRA gel, which showed some physical separation. EXAMPLE 2 Treatment of Patient A 20 1. Patient History The topical medicament prepared in Example 1 was used to treat a patient (hereinafter referred to as "Patient A"). Patient A was a Caucasian female in her 60s, and she was 5'7" and approximately 220 lb. Patient A exhibited neuropathy of the legs and feet, with the left leg being worse than the right. Patient A's big toe on her right foot and 25 second toe on her left foot were amputated within the preceding 3 years due to diabetes. She had received angioplasty about 9 months prior, and the angioplasty improved blood flow to her lower extremities. Both legs below the knees presented open sores about half-way between the knee caps and ankles. The sores were worse on the right leg than the left. She had used 30 Bactroban and Betadine to treat the topical sores for infection.

WO 2006/029189 PCT/US2005/031819 9 Patient A also had an ulcer on the bottom of her right foot. She had begun a second, 2-3 week treatment course of Regranex, applying at bedtime. Previous use of Regranex had worked, but the ulcer recurred, so she then had surgery. She began to use Etherex, which she stated is a generic medicine for Regranex and Bactroban. Her daily 5 medications are shown in Table A-B. Table A PRESCRIPTION MEDICATION DOSAGE Lisinopril 20/12.5 2 p.o. qd 10 Atenolol 50 mg 1 1/2 p.o. qd Lipitor 40 mg 1 p.o. qd Insulin 40u of N and 1Ou of Humalog in morning; 40u of N and lOu of Humalog before dinner Paroxitine (Paxil) 40 mg p.o. qd Levothyroxine 0.3 mg p.o. qd 15 Calcitrol 0.25 pg 1 p.o. bid Niaspan 500 mg 1 p.o. q evening Plavix 75 mg 1 p.o. qd Furosemide 80 mg p.o. 1 daily Diovan 320 mg 1 daily 20 Procrit 1 injection q 2 weeks until no longer needed Dynacirc 5 mg 1 p.o. daily WO 2006/029189 PCT/US2005/031819 10 Table B VITAMINS AND OVER-THE- DOSAGE COUNTER MEDICATIONS Multivitamin 1 p.o. daily 5 Prilosec 1 p.o. daily Low-Dose Aspirin 1 every evening Iron 2 "pills" each day for anemia Patient A also reported using Walitin (generic for Claritin) and Nasonex as needed 10 for allergies. 2. Treatment with Inventive Topical Medicament The ambient temperature during treatment ranged from 74-78*F according to measurements from four different Stress Thermometers used "as is" (Dr. Lowenstein's 15 Model SC911 accuracy +/- 1.8*F, 10 ft. lead with fast temperature sensor). Patient A was recumbent on a treatment table with a triangular pillow positioned behind both knees so that the knees were bent upward to rise above the ankles. A temperature probe was strapped on each upper ventral thigh and on the inside of each ankle. The probes were covered, and no medicament was applied to the probes. 20 Equilibration time was approximately 10 minutes after the patient reclined in the prone position. After equilibration time was reached, the temperatures were recorded as shown in Table C. Table C 25 PROBE LOCATION TEMPERATURE right thigh 90.0*F left ankle 86.7 0 F right thigh 92.3 0 F right ankle 90.1*F 30 WO 2006/029189 PCT/US2005/031819 11 The inventive medicament was applied to the top and bottom of each thigh and later (as shown in Table D) to the top and bottom of each calf, ankle, and foot. The product was massaged into the skin until nearly invisible to the eye. The dosage level was 0.3 oz. on each thigh and each ankle for a total per leg dosage of 0.6 oz. 5 Temperature readings were taken at intervals, beginning 5 minutes after application to Patient A's legs. These readings are set forth in Table D. Table D TIME LOCATION TEMPERATURE (*F) 10 5 minutesA left thigh 90.5 left ankle 86.9 right thigh 92.3 right ankle 90.9 15 Note - Patient A reported feeling heat at 5 minutes. 7 minutes left thigh 90.9 left ankle 86.9 right thigh 92.3 20 right ankle 90.9 10 minutes left thigh 91.5 left ankle 86.9 right thigh 92.5 25 right ankle 91.2 Note - Patient A reported heat at same level as at 5 minutes. 15 minutes left thigh 91.4 left ankle 87.1 WO 2006/029189 PCT/US2005/031819 12 TIME LOCATION TEMPERATURE (*F) right thigh 92.1 right ankle 90.7 Note - Patient A reported feeling a warm sensation. There was sweat behind the left knee. Medicament was applied to left ankle at 17 minutes. A paper towel was placed 5 on the triangular pillow. 20 minutes left thigh 91.2 left ankle 86.7 right thigh 91.9 10 right ankle 90.1 25 minutes left thigh 91.2 left ankle 86.5 right thigh 91.8 15 right ankle 90.3 30 minutes left thigh 91.2 left ankle 86.9 right thigh 91.6 20 right ankle 90.3 35 minutes left thigh 91.6 left ankle 86.9 right thigh 91.8 25 right ankle 90.5 Note - Medicament was applied to right ankle at 35 minutes. 40 minutes left thigh 91.4 WO 2006/029189 PCT/US2005/031819 13 TIME LOCATION TEMPERATURE (*F) left ankle 86.9 right thigh 90.3 right ankle 90.5 45 minutes 5 left thigh 91.2 left ankle 86.9 right thigh 88.7 right ankle 90.1 50 minutes 10 left thigh 91.2 left ankle 86.4 right thigh 89.2 right ankle 90.5 55 minutes 15 left thigh 91.2 left ankle 87.3 right thigh 89.4 right ankle 90.1 Note - At 57 minutes, Patient A reported a cool feeling from above the ankle to the 20 heel. 60 minutes left thigh 91.4 left ankle 87.3 right thigh 90.0 25 right ankle 90.1 65 minutes left thigh 91.2 WO 2006/029189 PCT/US2005/031819 14 TIME LOCATION TEMPERATURE (*F) left ankle 87.4 right thigh 90.5 right ankle 90.5 70 minutes 5 left thigh 91.0 left ankle 87.3 right thigh 90.7 right ankle 90.1 A Five minutes after application to left calf and lower thigh (0 time). 10 Patient A rose from the table at 78 minutes, and the thigh probes were removed. Patient A held the readout portion of the thermometers in her hand while the probes were still attached to the ankles to allow her to walk to the restroom and take a further readout 15 of her ankles after 5 minutes elapsed. However, at 82 minutes the left ankle probe came loose so no reading was taken. The right ankle probe gave a reading of 81.1*F at 82 minutes. Patient A reported that her left side (neuropathic side) felt soothed. EXAMPLE 3 20 Treatment of Patient B 1. Patient History The topical medicament prepared in Example 1 was used to treat a second patient (hereinafter referred to as "Patient B"). Patient B was a 60-year old, 5'7", Caucasian female. She was a non-insulin dependent diabetic and had sensory neuropathy that was 25 worse in her right leg. She did not have any visible wounds. Her daily oral medications were Glucophage (1 in the evening), Toprol, Diovan, and Lipitor (1 in the evening).

WO 2006/029189 PCT/US2005/031819 15 2. Treatment with Inventive Topical Medicament The ambient temperature during treatment ranged from 74-75*F according to measurements from the four different Stress Thermometers as described in Part 2 of Example 2. The probes were applied as described in Part 2 of Example 2. The initial 5 readings are shown in Table E. Table E PROBE LOCATION TEMPERATUREA TEMPERATUREc left thigh 88.7 0 F 89.1 0 F 10 left ankle 83.8 0 F 83.8 0 F right thigh 79.0FB 90.7 0 F right ankle 86.5 0 F 86.5 0 F A Temperature prior to medicament application. B The probe came loose from the right thigh, thus resulting in the 79*F reading. 15 c Temperature at 4 minutes after temperature reading in middle column. Temperature readings were taken as described in Part 2 of Example 2. These readings and the times of medicament application to Patient B's legs are set forth in Table F. 20 Table F TIME LOCATION TEMPERATURE (*F) 5 minutesA left thigh 90.5 25 left ankle 81.5 right thigh 91.6 right ankle 86.2 Note - The inventive medicament was applied to the entire left leg at 5 minutes. At 7 minutes, Patient B reported that her left leg was cool. 30 10 minutes left thigh 90.5 WO 2006/029189 PCT/US2005/031819 16 TIME LOCATION TEMPERATURE (*F) left ankle 81.5 right thigh 91.9 right ankle 85.8 15 minutes 5 left thigh 90.7 left ankle 81.5 right thigh 92.3 right ankle 85.8 20 minutes 10 left thigh 90.9 left ankle 81.1 right thigh 92.1 right ankle 85.5 Note - Patient B reported feeling a stinging sensation behind her left knee, and that the 15 toes on her left foot felt strange. 25 minutes left thigh 91.0 left ankle 81.1 right thigh 92.3 20 right ankle 84.7 Note - Patient B reported that she still felt a stinging sensation behind her left knee. 30 minutes left thigh 91.6 left ankle 81.1 25 right thigh 92.8 right ankle 84.7 WO 2006/029189 PCT/US2005/031819 17 TIME LOCATION TEMPERATURE (*F) 35 minutes left thigh 91.6 left ankle 81.1 right thigh 93.0 5 right ankle 82.9 Note - The inventive medicament was applied to the entire right leg at 35 minutes. 40 minutes left thigh 91.9 left ankle 81.0 10 right thigh 93.6 right ankle 83.3 45 minutes left thigh 92.1 left ankle 80.6 15 right thigh 93.6 right ankle 83.7 Note - Patient B reported feeling a burning on her left side. She stated that her right leg felt cool, and that she felt a sensation as if a thumb were being pressed into the middle of the arch on her right foot. She reported that she had a stress fracture of the calchaneal 20 bone on the right heel. 50 minutes left thigh 91.9 left ankle 80.2 right thigh 93.6 25 right ankle 83.7 Note - Patient B reported that she thought the doctor was touching her right foot, but he was not.

WO 2006/029189 PCT/US2005/031819 18 TIME LOCATION TEMPERATURE ('F) 55 minutes left thigh 91.9 left ankle 80.1 right thigh 93.7 5 right ankle 83.3 Note - Patient B reported that her left leg was feeling restless. 60 minutes left thigh 92.7 left ankle 80.1 10 right thigh 93.9 right ankle 83.3 65 minutes left thigh 93.0 left ankle 80.1 15 right thigh 94.1 right ankle 83.3 Note - Patient B rose at 66 minutes. 70 minutes left thigh 91.0 20 left ankle 79.7 right thigh 91.0 right ankle 82.8 A Five minutes after first temperature reading in Table E. 25 The probes were removed after 70 minutes.

WO 2006/029189 PCT/US2005/031819 19 EXAMPLE 4 Determination of Metabolic Activity The topical medicament prepared in Example 1 was applied to the left inner forearm (below the elbow) of a patient. The treated area was then swabbed with a glass 5 slide that was subsequently sandwiched between two ECG patches attached to leads to a Radio Shack digital, multi-meter. The initial reading (time =0) was 0.0 mV. Subsequent readings were taken at different intervals, and those results are reported in Table G. Table G 10 TIME READING (minutes after initial reading) (mV) 1 0.2 32 0.9 33 0.8 15 43 0.9 51 1.0 52 0.9 56 1.0 72 1.2 20 73 1.4 74 1.2 121 1.5 25 This test was carried out to show that oxygen activation from the compounded medicament occurs following the application to human skin with or without sweat. This test was repeated using medicament that had been swabbed from another patient's back. However, the cream turned green in color and did not reproduce similar results with the ECG patches. It also took about 6 hours and 20 minutes for this person to 30 notice the heat activation in the location where the medicament had been applied to the back.

20 EXAMPLE 5 Metabolic Activity Comparison In this test, the metabolic activity of the topical medicament prepared in Example I 5 was determined following the steps set forth in Example 4. The same steps were followed to determine the metabolic activity of two prior art products. Fig. 1 a shows the metabolic activity of one prior art product (non-modified SOMBRA) over a 45-minute time period. Fig. lb shows the metabolic activity of another prior art product (non- modified BIO-FREEZE) over a 45-minute time period. Fig. I c shows the inventive medicament's metabolic activity over a 45 10 minute time period. A comparison of these figures shows that metabolic activity of the prior art peaks and then drops substantially over the 45-minute time period while the inventive medicament's metabolic activity maintains very high levels even after peaking. Fig. Id shows the inventive medicament's metabolic activity over an 8-hour time period. This graph shows that this activity drops slowly over the 8-hour time period, thus providing prolonged treatment 15 periods as compared to prior art products. EXAMPLE 6 Treatment of Patient with Inventive Topical Medicament The patient in this example (hereinafter referred to as "Patient C") was a Caucasian 20 female in her late 50s. Patient C was suffering from neuropathy in her feet, with symptoms including sharp, stabbing pains and contractures due to over-stimulation of muscles. The condition had caused Patient C to take disability from work. The topical medicament prepared in Example I was applied to Patient Cs feet. Within 10 minutes, the contractures in her feet started to release, and she reported that her feet felt 25 90% better. Also, the sharp, stabbing pain was relieved for 6 hours after treatment. Throughout the description and claims of the specification, the word "comprise" and variations of the word, such as "comprising" and "comprises", is not intended to exclude other additives, components, integers or steps. 30

Claims

1. A topical medicament comprising menthol and camphor, said medicament 5 further comprising at least about 0.02% by weight potassium and a source of oxygen present at sufficient levels to provide an oxygen level of at least about 0.016% by weight, the percentages by weight being based upon the total weight of the medicament taken as 100% by weight. 10

2. The medicament of claim 1, wherein said medicament is in the form of a gel.

3. The medicament of claim I or claim 2, wherein said source of oxygen is selected from the group consisting of chlorites, spirulina, and mixtures of the foregoing. 15

4. The medicament of claim 3, wherein said source of oxygen is an alkali metal chlorite.

5. The medicament of claim 1, wherein said medicament comprises: at least about 0.5% by weight menthol, and 20 at least about 0.5% by weight camphor, based upon the total weight of the medicament taken as 100% by weight.

6. The medicament of any one of claims I to 5, wherein said medicament further comprises an ingredient selected from the group consisting of aloe vera extract, capsaicin, 25 carbomer, decyl plyglucose, deionized water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, silica, sodium hydroxymethyl glycinate, vegetable glycerin, witch hazel, yucca extract, carbonates, bicarbonates, and mixtures of the foregoing. 30

7. The medicament of any one of claims I to 6, wherein said medicament has a retained metabolic activity of at least about 20% over a 45-minute time period.

8. The medicament of any one of claims I to 7, wherein said medicament has a retained metabolic activity of at least about 5% over an 8-hour time period. 22

9. A method of treating a portion of a body afflicted with an ailment, said method comprising the step of contacting a medicament with the portion of the body afflicted with the ailment, said medicament comprising menthol, camphor, at least about 0.02% by weight 5 potassium, and a source of oxygen present at sufficient levels to provide an oxygen level of at least about 0.016% by weight, the percentages by weight being based upon the total weight of the medicament taken as 100% by weight.

10. The method of claim 9, wherein said contacting step comprises rubbing said 10 medicament into the portion of the body afflicted with the ailment.

11. The method of claim 8 or claim 9, wherein said medicament is in the form of a gel. 15

12. The method of any one of claims 9 to 11, wherein said source of oxygen is selected from the group consisting of chlorites, spirulina, and mixtures of the foregoing.

13. The method of claim 12, wherein said source of oxygen is an alkali metal chlorite. 20

14. The method of claim 9, wherein said medicament comprises: at least about 0.5% by weight menthol, and at least about 0.5% by weight camphor, based upon the total weight of the medicament taken as 100% by weight. 25

15. The method of any one of claims 9 to 14, wherein said medicament further comprises an ingredient selected from the group consisting of aloe vera extract, capsaicin, carbomer, decyl plyglucose, deionized water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, silica, sodium hydroxymethyl glycinate, 30 vegetable glycerin, witch hazel, yucca extract, and mixtures of the foregoing.

16. The method of any one of claims 9 to 15, wherein said medicament has a retained metabolic activity of at least about 20% 45 minutes after said contacting step. 23

17. The method of any one of claims 9 to 15, wherein said medicament has a retained metabolic activity of at least about 5% 8 hours after said contacting step.

18. A method of preparing a topical medicament, said method comprising the step 5 of mixing together menthol, camphor, at least about 0.02% by weight potassium, and a source of oxygen present at sufficient levels to provide an oxygen level of at least about 0.016% by weight, the percentages by weight being based upon the total weight of the medicament taken as 100% by weight. 10

19. The method of claim 18, wherein said method further comprises the steps of: (a) providing a precursor composition comprising said menthol and camphor; (b) adding said potassium to a quantity of said precursor composition to yield a first intermediate composition; 15 (c) alternately adding further quantities of said precursor composition and said potassium to said first intermediate composition to form a second intermediate composition; and (d) adding said source of oxygen to said second intermediate composition to yield the topical medicament. 20

20. The method of claim 18 or claim 19, further comprising the step of mixing said second intermediate composition prior to adding step (d).

21. A topical medicament comprising menthol and camphor, which medicament is 25 substantially as herein described with reference to Example 1.

22. Use of a medicament according to any one of claims 1 to 8 or 21 for treating a disease selected from diabetic neuropathy, post hepatic neuralgia, scleroderma, psoriasis, strain, spasticity, headaches, neuropathy secondary to drugs, peripheral neuropathy, leg pain, 30 muscle cramps, muscle aches and pains, bruise, sinusitis, sprain, arthritis, joint pain (arthralgia), and edema. 24

23. The use of a medicament according to any one of claims 1 to 8 or 21 for treating a portion of a body afflicted with an ailment, comprising the step of contacting the medicament with the portion of the body afflicted with the ailment. 5